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SOUTH SAN FRANCISCO, Calif., Feb. 28, 2019 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of serious cardiovascular diseases, today reported financial results for the fourth quarter and full year ended December 31, 2018.
“2018 was MyoKardia’s most significant year of progress towards building a leading cardiovascular company addressing the number one global health burden with novel precision medicines,” said Tassos Gianakakos, Chief Executive Officer. “Our commitment to a mission-driven, values-based culture continues to be a key differentiator as we build a growing community of employees motivated to change the world for people with serious cardiovascular diseases. We’ve added incredible people at all levels of the company and strengthened our HCM disease-area leadership. In 2018, we initiated six clinical trials for mavacamten and MYK-491, including the pivotal Phase 3 EXPLORER-HCM trial, shared important clinical data from both, and unveiled three new therapeutic programs, including MYK-224 which will enter the clinic this year.”
Gianakakos continued, “As we move into 2019, our pipeline is set up to generate meaningful clinical data across multiple programs, including six-month mavacamten data from our open-label PIONEER-OLE study to be presented at the upcoming American College of Cardiology annual meeting. Over the course of the year, we will report additional 12-month clinical data from PIONEER-OLE and complete enrollment for our Phase 3 EXPLORER-HCM trial, bringing us closer to delivering much-needed new therapies to people with HCM. Phase 2 data from our MAVERICK study of mavacamten in non-obstructed HCM is expected later this year and will generate important insights towards addressing diastolic heart disease. We also expect to share Phase 2 data from our MYK-491 program designed to improve systolic function in people with impaired cardiac contractility.”
MyoKardia’s management will conduct a conference call on Monday, March 4 at 8:30 a.m. ET/5:30 a.m. PT to discuss fourth quarter and year-end 2018 financial results. The call and webcast will also review six-month safety, efficacy and biomarker data from the PIONEER open-label extension (OLE) trial of mavacamten in patients with obstructive HCM. These data will become available electronically on March 4th and will be presented at the American College of Cardiology’s 68th Annual Scientific Session being held March 16-18 in New Orleans.
Therapeutic Program Highlights
Mavacamten for Hypertrophic Cardiomyopathy (HCM)
Recent Corporate Highlights
Fourth Quarter and Full Year 2018 Financial Results
Based on its current operating plans, MyoKardia anticipates that current cash, cash equivalents and investments are sufficient to fund operations into late 2020.
Conference Call and Webcast
MyoKardia management will host a conference call and live audio webcast on Monday, March 4, 2019, at 8:30 a.m. ET / 5:30 a.m. PT to discuss current operations and fourth quarter and year end 2018 financial results and review new data from the PIONEER-OLE study. The call may be accessed by phone by calling 844-494-0193 from the U.S. and Canada or 508-637-5584 internationally and using the conference ID 7688075. The webcast may be accessed live on the Investor Relations section of the Company's website at http://investors.myokardia.com. A replay of the webcast will be available on the MyoKardia website for 90 days following the call.
MyoKardia is a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious cardiovascular diseases. MyoKardia’s initial focus is on the development of small molecule therapeutics aimed at the cardiac muscle proteins that modulate cardiac muscle contraction and underlie diseases of systolic and diastolic dysfunction. Based on an in-depth understanding of disease biology, MyoKardia applies a precision medicine approach to develop its therapeutic candidates for patient populations with shared characteristics, such as causal genetic mutations or disease subtypes. MyoKardia’s most advanced product candidate is mavacamten (formerly MYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten has advanced into a pivotal Phase 3 clinical trial, known as EXPLORER-HCM in patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM). MyoKardia is also developing mavacamten in a second indication, non-obstructive HCM, in the Phase 2 MAVERICK-HCM clinical trial. MYK-491, MyoKardia’s second product candidate, is designed to increase cardiac output among patients with systolic heart dysfunction by increasing the overall extent of the heart’s cardiac contractility. MyoKardia is currently evaluating MYK-491 in a Phase 1b/2a study in stable heart failure patients.
MyoKardia’s mission is to change the world for patients with serious cardiovascular disease through bold and innovative science.
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the clinical and therapeutic potential of mavacamten and MYK-491, the Company’s ability to enroll patients in its Phase 3 EXPLORER-HCM study of mavacamten in symptomatic oHCM, the Company’s ability to enroll patients in its Phase 2 MAVERICK-HCM study of mavacamten in nHCM, the Company’s ability to enroll patients in its long-term safety studies, PIONEER-OLE and MAVA-LTE, and the availability of data from EXPLORER-HCM, MAVERICK-HCM, the MYK-491 Phase 2a multiple ascending dose trial and PIONEER-OLE and MAVA-LTE, the Company’s expectation with respect to release of data from these studies, the Company’s ability to advance additional research programs into clinical development, and the timing of these events, as well as the Company’s projected cash runway, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates, as well as those set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, and our other filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Senior Director, Corporate Communications and Investor Relations
Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
Steven Cooper (media)
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)|
|As of December 31,|
|Cash and cash equivalents||$||246,122||$||224,571|
|Receivable from collaboration partner||—||1,013|
|Prepaid expenses and other current assets||4,760||1,876|
|Total current assets||319,446||259,393|
|Property and equipment, net||5,138||3,147|
|Restricted cash and other||2,521||368|
|Liabilities and stockholders’ equity|
|Prepayment from collaboration partner||12,973||4,432|
|Total current liabilities||36,677||51,930|
|Other long-term liabilities||9||202|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and
|Common stock, $0.0001 par value, 150,000,000 shares authorized at December 31, 2018
and 2017; 40,288,949 and 35,812,791 shares issued and outstanding at December 31,
2018 and 2017, respectively
|Additional paid-in capital||573,183||365,719|
|Accumulated other comprehensive loss||(67||)||(192||)|
|Total stockholders’ equity||370,567||230,676|
|Total liabilities and stockholders’ equity||$||407,253||$||282,808|
|Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share amounts)|
|Year Ended December 31,|
|Collaboration and license revenue||$||33,558||$||11,442||$||41,971|
|Research and development, net||68,774||48,136||36,215|
|General and administrative||38,435||21,973||16,289|
|Total operating expenses||107,209||70,109||52,504|
|Loss from operations||(73,651||)||(58,667||)||(10,533||)|
|Interest and other income, net||5,953||1,657||153|
|Other comprehensive income (loss)||125||(200||)||8|
|Net loss per share, basic and diluted||$||(1.76||)||$||(1.74||)||$||(0.38||)|
|Weighted average number of shares used to compute net loss
per share, basic and diluted